Neo Shirlyn Hui-Shan, Yu Ke, Lee Chun Fan, Cheung Yin Bun
Division of Supportive and Palliative Care, National Cancer Centre Singapore, Singapore
Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.
BMJ Open. 2025 Mar 27;15(3):e100581. doi: 10.1136/bmjopen-2025-100581.
Palliative care (PC) improves quality of life (QOL). However, PC is currently delivered 'too little, too late' in heart failure (HF). Timely interventions to enable and reach patients with HF and their caregivers, with PC (TIER-HF-PC) is a novel, nurse coach-led model of PC that integrates PC into HF care. We will compare the effectiveness of TIER-HF-PC against usual care for improving patient and caregiver health outcomes. We will also evaluate implementation outcomes (such as care experience) of TIER-HF-PC.
In TIER-HF-PC, patients undergo regular distress screening. The intensity of PC treatments will be tiered based on the severity of problems detected. Minimally, all patients will receive PC education resources. Patients with moderate-intensity needs will receive PC health coaching. Patients with high-intensity needs will receive a PC physician consultation, on top of PC health coaching. Patients in usual care are not screened but can be referred to a PC physician based on cardiologist discretion.We will recruit 240 English- or Mandarin-speaking patients with HF and up to 240 caregivers from 3 sites across 2 cardiac centres. Patients will be randomised in a 1:1 ratio to TIER-HF-PC or usual care. We will use an intention-to-treat approach for data analysis. Our primary outcome is patient QOL on the Kansas City Cardiomyopathy Questionnaire at 24 weeks. Secondary outcomes include patient healthcare utilisation, caregiver QOL and cost-effectiveness. All participants who received PC treatments will receive a service evaluation survey. Additionally, a sample of these participants and their treating healthcare staff will be purposively recruited for in-depth semistructured interviews on their TIER-HF-PC experience. Interviews will be thematically analysed. We will evaluate protocol fidelity through case notes and study process audits.
This study was approved by the SingHealth Institutional Ethics Review Board-review number: 2024-2213. Results of the study will be disseminated when data analysis is complete.
NCT06244953.
姑息治疗（PC）可提高生活质量（QOL）。然而，目前心力衰竭（HF）患者接受的姑息治疗“太少、太晚”。心力衰竭患者及照护者及时接受姑息治疗干预（TIER-HF-PC）是一种新型的、由护士指导的姑息治疗模式，将姑息治疗融入心力衰竭护理中。我们将比较TIER-HF-PC与常规护理在改善患者和照护者健康结局方面的有效性。我们还将评估TIER-HF-PC的实施效果（如护理体验）。
在TIER-HF-PC模式中，患者要接受定期的痛苦筛查。姑息治疗的强度将根据检测到的问题严重程度进行分级。所有患者至少会收到姑息治疗教育资源。中度需求的患者将接受姑息治疗健康指导。高强度需求的患者除了接受姑息治疗健康指导外，还将接受姑息治疗医生会诊。常规护理的患者不进行筛查，但可根据心脏病专家的判断转介给姑息治疗医生。我们将从2个心脏中心的3个地点招募240名说英语或普通话的心力衰竭患者以及最多240名照护者。患者将按1:1的比例随机分配到TIER-HF-PC组或常规护理组。我们将采用意向性分析方法进行数据分析。我们的主要结局是24周时患者在堪萨斯城心肌病问卷上的生活质量。次要结局包括患者的医疗保健利用率、照护者的生活质量和成本效益。所有接受姑息治疗的参与者都将收到一份服务评估调查问卷。此外，将有目的地招募这些参与者及其治疗医护人员的样本，就他们的TIER-HF-PC体验进行深入的半结构化访谈。访谈将进行主题分析。我们将通过病例记录和研究过程审核来评估方案的依从性。
本研究已获得新加坡健康城机构伦理审查委员会批准——审查编号：2024-2213。数据分析完成后将公布研究结果。
NCT06244953。
